Note: Descriptions are shown in the official language in which they were submitted.
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IMPROVED ANTIPERSPIRANT METHODS AND COMPOSITIONS
FIELD OF THE INVENTION
The present invention relates to antiperspirant compositions and corresponding
methods
of application wherein the compositions comprise skin-adhering polymers for
enhanced
substantivity of antiperspirant actives.
BACKGROUND OF THE 1NVENTION
Many topical antiperspirant products are commercially available in a variety
of
formulations and product forms. These products typically contain a solid
and/or liquid carrier in
combination with an antiperspirant active. Antiperspirant actives help to
reduce or eliminate
perspiration on the underarm or other areas of the skin. It is believed that
these antiperspirant
actives work by dissolving in sweat after application, diffusing as a
dissolved material into the
sweat ducts, and then precipitating in the sweat ducts to form a plug that
inhibits the flow of
perspiration. Although the antiperspirant actives are capable of providing
this function, the
actives are not able to achieve optimum performance due to their inability to
adhere to the skin.
After application, most of the actives flake off or are transferred from the
skin onto clothing or
other material thereby leaving only a minimal amount of active available to
inhibit the flow of
perspiration.
The present invention provides alternative antiperspirant compositions to
those that are
currently available or otherwise known in the art. The present invention also
provides such
alternative compositions through the use and application of skin adhering
polymers contained by
or within a suitable volatile anhydrous carrier. Further, the present
invention provides such
alternative compositions with improved antiperspirant efficacy.
SUMMARY OF THE INVENTION
The present invention provides an antiperspirant with novel compositions that
allow for
retention of actives on the skin in order to alleviate or prevent the flow of
perspiration. These
compositions comprise a skin-adhering system comprising skin adhering-polymers
and one or
more volatile solvents. The skin-adhering polymer in combination with the
volatile solvent form a
system that works to retain the antiperspirant actives on the skin thereby
improving the efficacy of
the actives to prevent or inhibit sweat. The present invention is also
directed to methods for
inhibiting or preventing perspiration by topically applying to the underarm or
other appropriate
area of skin a composition comprising a skin-adhering system as described
herein, in addition to
antiperspirant actives, thickening agents and an anhydrous carrier.
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It has been found that the topical antiperspirant compositions and methods of
application
as disclosed herein provide alternative antiperspirant formulations and
methods from those
commercially available or otherwise known. It has also been found that these
compositions and
applied methods provide improved antiperspirant efficacy and/or cosmetics as
compared to many
other more traditional antiperspirant products.
DETAILED DESCRIPTION OF THE INVENTION
The antiperspirant compositions and methods of the present invention can
comprise,
consist essentially of, or consist of, the essential components as well as
optional ingredients
described herein. As used herein, "consisting essentially of ' means that the
composition or
component may include additional ingredients, but only if the additional
ingredients do not
materially alter the basic and novel characteristics of the claimed
compositions or methods.
All percentages, parts and ratios are based upon the total weight of the
topical
compositions of the present invention and all measurements made are at
25°C, unless otherwise
specified. All such weights as they pertain to listed ingredients are based on
the active level and,
therefore, do not include Garners or by-products that may be included in
commercially available
materials, unless otherwise specified.
The term "anhydrous" as used herein, unless otherwise specified, refers to
those materials
or compositions that are substantially free of added water. As it pertains to
the compositions of
the present invention, this means that the compositions are essentially free
of added water. The
term "anhydrous", however, as used herein can also mean that the composition
contains water but
that the water is isolated. The term "anhydrous" as used herein generally
means that the material
or composition preferably contains less than 1%, preferably less than 0.5%,
more preferably zero
percent, by weight of free or added water.
The term "antiperspirant efficacy" as used herein, unless otherwise specified,
refers to
any incremental sweat reduction resulting from an antiperspirant composition
as a result of the
addition of the skin-adhering polymer and volatile anhydrous carrier described
herein. Sweat
reduction is determined by the hot room procedure described in US 6,352,688,
Scavone, issue
date March S, 2002.
The term "skin-adhering polymer" as used herein, unless otherwise specified,
refers to
those polymers that when applied to skin form flexible substantive films.
These materials
function as substantivity aids to trap or hold the active onto the skin for a
time sufficient to
provide the desired efficacy benefit. In the case of antiperspirants, the
polymer maintains
adhesion to skin through multiple sweat events, thus the antiperspirant active
is available longer
thereby providing the advantageous efficacy benefit.
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The term "volatile solvent" of the present invention refers to solvents that
exhibit vapor
pressures of at least about 0.10, preferably at least about 1.00 and no more
than about 10.00,
preferably no more than about 100.00 (mmHg) at about 20°C.
The term "skin-adhering system" as used herein refers to the combination of
one or more
skin-adhering polymers and one or more volatile solvents. The skin-adhering
polymer in
combination with the volatile solvent form a system that works to retain the
antiperspirant actives
on the skin thereby improving the efficacy of the actives to prevent or
inhibit sweat.
"Sufficient film-formation" as used herein describes the ability of the skin-
adhering
polymer to form a cohesive film.
The term "ambient conditions" as used herein, refers to surrounding conditions
at about
one atmosphere of pressure (1 atm), at about 50% relative humidity, unless
otherwise specified.
All values, amounts and measurements described herein are obtained under
ambient conditions
unless otherwise specified.
The essential elements of the antiperspirant compositions of the present
invention,
including the essential elements of the corresponding methods of application,
are described in
greater detail hereinafter.
Skin-AdherinE Polymers
The antiperspirant compositions of the present invention comprise skin-
adhering
polymers. By being skin-adhering polymers, the polymers suitable for use in
the present
invention readily adhere to and form films on skin, thereby depositing the
active incorporated
with the polymers in the composition onto the skin. The polymers may be
completely soluble or
dispersible in the anhydrous Garner. Polymers of the present invention
include, but are not
limited to, acrylate polymers/co-polymers and silicone polymers/co-polymers.
Examples of
acrylate co-polymers include, but are not limited to, various combinations of
acrylate and/or
methacrylate monomers, including acrylic-ester and acrylic-acid monomers.
Examples of
silicone-modified co-polymers include, but are not limited to, silicone-
acrylate copolymers,
silicone-urethane copolymers, silicone-malefic anhydride copolymers, silicone
resin copolymers,
and mixtures thereof.
The skin-adhering polymers suitable for use in the compositions and methods of
the
present invention will generally have a relatively low glass transition
temperature (Tg). In order
to prevent or minimize flaking on the skin, it is suitable for the Tg to be
within a range that allows
flexibility of the polymer. Thus, it is preferred that compositions of the
present invention include
a Tg from at least about -30°C, more preferably at least about
0°C, even more preferably at least
about 3°C. The Tg of the present invention should be no more than about
30°C, more preferably
no more than about 20°C, even more preferably no more than about
10°C.
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It is preferred that the skin-adhering polymers of the present invention
exhibit a number
average molecular weight that allows for sufficient film-formation to the
skin. Useful skin-
adhering polymers of the present invention exhibit sufficient film-formation
at or above the
entanglement molecular weight according to the polymer used. For example, when
a silicone-
acrylate copolymer is used in compositions of the present invention, the
molecular weight is at or
about 400,000 g/mol number average for sufficient film-formation.
The concentration of the skin-adhering polymers in the composition should be
sufficient
to provide the desired antiperspirant efficacy when used in combination with
conventional
antiperspirant actives. Applicants of the present invention have found that
the skin-adhering
polymer will typically range from at least about 0.1%, preferably from at
least about 2%, more
preferably from at least about 3%, even more preferably from at least about 4%
to no more than
about 30%, preferably no more than about 20%, more preferably no more than
about 15%, even
more preferably no more than about 10%, by weight of the composition. Polymers
of the present
invention should be included such that a suitable amount of polymer attaches
to the skin without
inhibiting release of the antiperspirant active ingredients and without
aesthetic trade-offs. Thus, a
ratio of weight compositions of polymer to thickening agent should be
considered such that the
weight composition of polymer is directly proportional to the weight
composition of thickening
agent. The ratio of weight compositions of polymer to thickening agent (in
semi-solid form)
suitable for the present invention should include the weight composition of
polymer to be no more
than about 2, preferably no more than about 1.5, more preferably no more than
about 1, even more
preferably no more than about 0.64, still more preferably no more than about
0.5 directly
proportional to the weight composition of thickening agent which, is at least
about 1.
Volatile Solvent
The antiperspirant compositions of the present invention also comprise
volatile solvents.
Suitable volatile solvents exhibit vapor pressures of at least about 0.10,
preferably at least about
1.00 and no more than about 10.00, preferably no more than about 100.00 (mmHg)
at about 20°C.
The function of the volatile solvent as part of the skin-adhering system is to
aid in rapid film
formation by evaporating quickly on skin to leave behind the polymer film,
active, and other
components. This prevents product transfer prior to dry down. In addition, by
evaporating
rapidly, the volatile solvent leaves physical channels in the dried
polymer/antiperspirant film.
This aids in rapid dissolution of the active in the dried
polymer/antiperspirant film during a sweat
event. Volatile solvents of the present invention include, but are not limited
to, alcohols, silicone
fluids, fluorinated solvents and mixtures thereof. Alcohols of the present
invention may include
polar, nonpolar, organic, non- organic carriers and mixtures thereof that are
known for use in
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antiperspirant/deodorant or other personal care products, or which are
otherwise suitable for
topical applications to skin. Particularly preferred alcohols include ethanol,
propanol, isopropanol
and mixtures thereof. The concentration of the volatile solvents of the
present invention will
typically range from at least about 0.1%, preferably from at least about 2%,
more preferably from
at least about 3%, even more preferably from at least about 5% to no more than
about 60%,
preferably no more than about 50%, more preferably no more than about 40%,
even more
preferably no more than about 30%, by weight of the composition.
Antiperspirant Actives
Antiperspirant actives suitable for use in the compositions of the present
invention
include any compound, composition or other material having antiperspirant
activity. Preferred
actives comprise astringent metallic salts, especially the inorganic salts of
aluminum zirconium
and zinc, as well as mixtures thereof. Particularly preferred are the aluminum
and zirconium
salts, such as aluminum halides, aluminum chlorohydrate, aluminum
hydroxyhalides, zirconyl
oxyhalides, zirconyl hydroxyhalides, and mixtures thereof.
Preferred aluminum salts for use in the composition include those that conform
to the
formula:
A12(OH)aClb ~ xH20
wherein a is from about 2 to about 5; the sum of a and b is about 6; x is from
about 1 to about 6;
and wherein a, b, and x may have non-integer values. Particularly preferred
are the aluminum
ehlorohydroxides referred to as "5/6 basic chlorohydroxide", wherein a=5, and
"2/3 basic
chlorohydroxide", wherein a=4. Processes for preparing aluminum salts are
disclosed in U.S. Pat.
No. 3,887,692, Gilman, issued Jun. 3, 1975; U.S. Pat. No. 3,904,741, Jones et
al., issued Sep. 9,
1975; U.S. Pat. No. 4,359,456, Gosling et al., issued Nov. 16, 1982; and
British Patent
Specification 2,048,229, Fitzgerald et al., published Dec. 10 1980. Mixtures
of aluminum salts
are described in British Patent Specification 1,347,950, shin et al.,
published Feb. 27, 1974.
Preferred zirconium salts for use in the composition include those that
conform to the
formula:
Zr0(OH)Z.aCIQ~ xHzO
Wherein a is from about l .l to about 2.0; x is from about 1 to about 8; and
wherein a and x may
both have non-integer values. These zirconium salts are described in Belgian
Patent 825,146,
Schmitz, issued Aug. 4, 1975, which description is incorporated herein by
reference. Particularly
preferred zirconium salts are those complexes that additionally contain
aluminum and glycine,
commonly know as ZAG complexes. These ZAG complexes contain aluminum
chlorohydroxide
and zirconyl hydroxy chloride conforming to the above described formulas. Such
ZAG
complexes are described in U.S. Pat. No. 3,679,068, Luedders et al., issued
Feb. 12, 1974; Great
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Britain Patent Application 2,144,992, Callaghan et al., published Mar. 20,
1985; and U.S. Pat. No.
4,120,94, Shelton, issued October 17, 1978.
The concentration of the antiperspirant actives of the present invention will
typically
range from at least about 0.1%, preferably from at least about 2%, more
preferably from at least
about 3%, even more preferably from at least about 5% to no more than about
30%, preferably no
more than about 27%, more preferably no more than about 25%, even more
preferably no more
than about 20%, by weight of the composition.
Thickening Agent
The antiperspirant compositions of the present invention also comprise
thickening agents
to help provide the composition with the desired viscosity, rheology, texture
and/or product
hardness, or to otherwise help suspend any dispersed solids or liquids within
the composition.
The term "thickening agent" includes any material known or otherwise effective
in providing
suspending, gelling, viscosifying, solidifying or thickening properties to the
composition or which
otherwise provide structure to the final product form. These thickening agents
include gelling
agents, and polymeric or nonpolymeric or inorganic thickening or viscosifying
agents. The
thickening agents will most typically include organic solids, silicone solids,
crystalline or other
gellants, inorganic particulates such as clays or silicas, or combinations
thereof.
The concentration and type of the thickening agent selected for use in the
antiperspirant
composition will vary depending upon the desired product form, viscosity, and
hardness. Most
thickening agents suitable for use herein, will have a concentration range
from at least about
0.1%, more preferably from at least about 3%, even more preferably from at
least about 5% to no
more than about 35%, more preferably no more than about 20%, even more
preferably no more
than about 10%, by weight of the composition.
Non limiting examples of suitable gelling agents of the present invention
include fatty
acid gellants, salts of fatty acids, hydroxyl acids, hydroxyl acid gellants,
esters and amides of fatty
acid or hydroxyl fatty acid gellants, cholesterolic materials, dibenzylidene
alditols, lanolinolic
materials, fatty alcohols, triglycerides, sucrose esters such as SEFA
behenate, inorganic materials
such as clays or silicas, other amide or polyamide gellants, and mixtures
thereof. Concentrations
of all such gelling agents are preferably from at least about 0.1 %, more
preferably from at least
about 1%, even more preferably from at least about 5% and no more than about
25%, more
preferably no more than about 15%, even more preferably no more than about
10%, by weight of
the composition.
Suitable gelling agents include fatty acid gellants such as fatty acid and
hydroxyl or alpha
hydroxyl fatty acids, having from about 10 to about 40 carbon atoms, and ester
and amides of
such gelling agents. Non-limiting examples such gelling agents include 12-
hydroxystearic acid,
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12-hydroxylauric acid, 16-hydroxyhexadecanoic acid, behenic acid, eurcic acid,
stearic acid,
caprylic acid, lauric acid, isostearic acid, and combinations thereof.
Preferred are 12-
hydroxystearic acid, esters of 12-hydroxystearic acid, amides of 12-
hydroxystearic acid and
combinations thereof.
Other suitable gelling agents include amide gellants such as disubstituted or
branched
monoamide gellants, monsubstituted or branched diamide gellants, triamide
gellants, and
combinations thereof, including n-acyl amino acid derivatives such as n-acyl
amino acid amides,
n-acyl amino acid esters prepared from glutamic acid, lysine, glutamine,
aspartic acid, and
combinations thereof. Other suitable amide gelling agents are described in
U.S. Pat. No.
5,429,816, issued Jul. 4, 1995, and U.S. patent application Ser. No.
08/771,183, filed Dec. 20,
1996.
Still other examples of suitable gelling agents include fatty alcohols having
at least from
about 8 carbon atoms, preferably from at least about 12 carbon atoms and no
more than about 40
carbon atoms, preferably no more than about 30 carbon atoms, more preferably
no more than
about 18 carbon atoms. Preferred fatty alcohols, but are not limited to cetyl
alcohol, myristyl
alcohol, stearyl alcohol and combinations thereof, more preferably stearyl
alcohol.
Non limiting examples of suitable tryiglyceride gellants include tristearin,
hydrogenated
vegetable oil, trihydroxysterin (Thixcin~ R, available from Rheox, Inc.), rape
seed oil, castor
wax, fish oils, tripalmitin, Syncrowax~ HRC and Syncrowax~ HGL-C (Syncrowax~
available
from Croda, Inc.).
Other suitable thickening agents include waxes or wax-like materials having a
melt point
of above 65°C, more typically from about 65°C to about
130°C, examples of which include, but
are not limited to, waxes such as beeswax, carnauba, bayberry, candelilla,
montan, ozokerite,
ceresin, hydrogenated castor oil (castor wax), synthetic waxes and
microcrystalline waxes. Castor
wax is preferred within this group. Other high melting point waxes are
described in U.S. Pat. No.
4,049,792, Elsnau, issued Sep. 20, 1977.
Further thickening agents for use in the antiperspirant compositions of the
present
invention include inorganic particulate thickening agents such as clays and
colloidal pyrogenic
silica pigments. Preferably, colloidal pyrogenic silica pigments are used. One
common example
includes Cab-O-Sil~, a submicroscopic particulated pyrogenic silica. Other
known or otherwise
effective inorganic particulate thickening agents that are commonly used in
the art can also be
used in the antiperspirant compositions of the present invention.
Concentrations of particulate
thickening agents preferably range from at least about 0.1 %, more preferably
from at least about
1%, even more preferably from at least about 5% to no more than about 15%,
more preferably no
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more than about 10%, even more preferably no more than about 8%, by weight of
the
composition.
Suitable clay thickening agents include montmorillonite clays, examples of
which include
bentonites, hectorites, and colloidal magnesium aluminum silicates. These and
other suitable
clays are preferably hydrophobically treated, and when so treated will
generally be used in
combination with a clay activator. Non-limiting examples of suitable clay
activators include
propylene carbonate, ethanol, and combinations thereof. When clay activators
are present, the
amount of clay activator will typically range from at least about 40%, more
preferably from at
least about 25%, even more preferably from at least about 15% to no more than
about 75%, more
preferably no more than about 60%, even more preferably no more than about
50%, by weight of
the clay.
Anhydrous Carrier
The antiperspirant compositions of the present invention also comprise
anhydrous
carriers. Anhydrous carriers of the present invention include, but are not
limited to silicone fluids.
The silicone fluid is preferably a cyclic silicone, more preferably a cyclic
silicone having from at
least about 3 silicone atoms, even more preferably at least about 5 silicone
atoms but no more
than about 7 silicone atoms, more preferably no more than about 6 silicone
atoms.
The concentration of the anhydrous carrier useful in the present invention
will typically
range from at least about 10%, preferably from at least about 15%, more
preferably from at least
about 20%, even more preferably from at least about 25% to no more than about
70%, preferably
no more than about 65%, more preferably no more than about 60%, even more
preferably no
more than about 50%, by weight of the composition.
Optional Materials
The antiperspirant compositions of the present invention may further comprise
other
optional materials known for use in antiperspirant, deodorant or other
personal care products,
including those materials that are known to be suitable for topical
application to skin. Non
limiting examples include dyes or colorants, fragrances, emulsifiers,
distributing agents,
pharmaceuticals or other topical actives, deodorant agents, antimicrobials,
preservatives,
surfactants, processing aides such as viscosity modifiers and wash-off aids.
Examples of such
optional materials are described in U.S. Pat. No. 4,049,792 (Elsnau); U.S.
Pat. No. 5,019,375
(Ianner et al.) and U.S. Pat. No. 5,429,816 (Hofrichter et al.).
Product Form
The antiperspirant compositions of the present invention can be formulated as
any known
or otherwise effective product form for providing topical application of
antiperspirant or
deodorant active to the desired area of the skin. Non-limiting examples of
such product forms
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include liquids (e.g., aerosols, pump sprays, roll-ons), solids (e.g., gel
solids, invisible solids, wax
solid sticks), semi-solids (e.g. creams, soft solids, lotions), and the like.
Preferably, the
antiperspirant compositions of the present invention are semi-solids or
solids.
The antiperspirant products are generally stored in and dispensed from a
suitable package
or applicator device, such as a cream dispenser with perforated application
domes, etc. These
packages should be sufficiently closed to prevent excessive loss of volatiles
prior to application.
Method of Manufacture
The antiperspirant compositions of the present invention may be prepared by
any known
or otherwise effective technique, suitable for providing an anhydrous
composition of the desired
form and having the essential materials described herein. Many such techniques
are described in
the antiperspirant/deodorant formulation arts for the described product forms.
Method of Use
The antiperspirant compositions of the present invention may be applied
topically to the
underarm or other suitable area of the skin in an amount effective to reduce
or inhibit perspiration
wetness. Preferably, compositions of the present invention is applied in an
amount ranging from
at least about 0.1 gram to no more than about 20 grams, preferably no more
than about 10 grams,
more preferably no more than about 1 gram. The composition is preferably
applied to the
underarm at least about one or two times daily, preferably once daily, to
achieve effective
antiperspirant reduction or inhibition over an extended period.
The antiperspirant composition can also be applied every other day, or every
third or
fourth day, and then optionally to supplement application on off days with
other personal care
products such as deodorants and/or conventional antiperspirant formulations.
Compositions of the present invention are preferably applied to skin, wherein
the volatile
anhydrous carrier leaves behind a skin-adhering polymer and active-containing
film. This film is
positioned over the sweat ducts and resists flaking and/or rub-off, thereby
being present through
multiple perspiration episodes.
EXAMPLES
The composition described in Table 1 is an antiperspirant composition in the
form of a
semi-solid (cream). This exemplified composition can be prepared by methods
well known in the
art for creams, some examples of which are described in U.S. Pat. No.
6,187,300 (Motely et al.).
All exemplified amounts are weight percentages based on the total weight of
the
antiperspirant composition, unless otherwise specified. Examples of the
present invention are not
intended to be limiting thereof
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TABLE 1
Semi-solid (Cream) Antiperspirant Stick
Ingredients Weight (%)
A1 Zr trichlorohydrex 25.25
Isopropanol 43.5
Cyclomethicone, D5z 15.0
Dimethicone (10 cs) 5.0
C20-C40 alcohols3 S.0
Skin-Adhering Polymer 4.0
C18-36 triglyceride combination1.25
Fragrance 1.0
Supplied by Westwood Chemical Corporation
ZCyclic polydimethylsiloxane containing 5 carbons, supplied by G.E. Silicones
3Syncrowax HGL-C from Croda
The composition described in Table 2 is an antiperspirant composition in the
form of a solid stick.
This exemplified composition can be prepared by methods well known in the art
for preparing
such product forms, examples of such methods including those described in U.S.
Pat. No.
4,985,238 (Tanner et al.).
TABLE 2
Solid Antiperspirant Stick
Ingredients Weight (%)
A1 Zr trichlorohydrex 20.0
Stearyl Alcohol 12.0
Cyclomethicone, DS 50.0
Talc 10.0
Skin-Adhering Polymer 3.0
Hydrogenated castor oil 3.0
Fragrance 1.0
Silica 0.4
Microthene 0.4
Behenyl Alcohol 0.2
The compositions described in Table 3 are antiperspirant compositions in the
form of roll-on
liquids and aerosols. Each of these exemplified compositions can be prepared
by methods well
known in the art for preparing such product, forms, examples of such methods
including those
described in U.S. Pat. No. 4,904,463 (Johnson et al.) and U.S. Pat. No.
5,298,236 (Orr et al.).
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TABLE 3
Liquid Antiperspirant Roll-Ons and Aerosols
Ingredients Weight (%) Weight (%)
(Roll-On) (Aerosol)
_ 3.0 4.0
Skin-Adhering Polymer
Cyclohexasiloxane 40.3 12.4
Dimethiconol 80 cs 10.0 --
Dimethicone 50 cs -- 5.0
Mineral Oil 10.0 --
Al Zr trichlorohydrex 25.0 --
gly.
Quaternium-18 Hectorite4.0 1.0
HL
Propylene Carbonate 1.0 0.3
Dipropylene glycol 0.9 --
Polyethylene powder 5.5 --
A1 chlorohydrate -- 12.0
Propellant -- 60.0
Isopropyl myristate -- 5.0
Perfume 0.3 0.3
The antiperspirant composition described in Table 4 is in the form of an
emulsion. This
exemplified composition can be prepared by methods well known in the art for
emulsions, some
examples of which are described in U.S. Pat. No. 4,673,570 (Soldati).
TABLE 4
Antiperspirant Emulsion
Ingredients Weight (%)
A1 Zr trichlorohydrex glycinate20.0
Skin-Adhering Polymer 4.0
Cyclohexasiloxane 6.0
Cyclomethicone (and) dimethicone15.0
copolyol DC 3225C
PPG-15 Stearyl Ether 9.0
Perfume 1.0
Water 45.0
All documents cited in the Detailed Description of the Invention are, in
relevant part,
incorporated herein by reference; the citation of any document is not to be
construed as an
admission that it is prior art with respect to the present invention.
While particular embodiments of the present invention have been illustrated
and
described, it would be obvious to those skilled in the art that various other
changes and
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12
modifications can be made without departing from the spirit and scope of the
invention. It is
therefore intended to cover in the appended claims all such changes and
modifications that are
within the scope of this invention.
